Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis (PLACEBO)

Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)

An observational, prospective, cohort study aiming to assess the potential predictive role of cardiopulmonary exercise testing in the prognosis of paroxysmal atrial fibrillation, in combination with echocardiographic indices and plasma biomarker values.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Arrhythmia
• Intervention / Treatment: Diagnostic test: Observation group

Detailed Description

The "ParoxysmaL Atrial fibrillation prognosis based on Cardiopulmonary Exercise test data and novel echocardiographic and plasma BiOchemical indices" (PLACEBO) trial comprises an observational, prospective, single-center cohort study including patients with paroxysmal atrial fibrillation. All patients undergo clinical examination, detailed echocardiographic study, cardiopulmonary exercise testing (CPET) and 24-hour ambulatory echocardiographic monitoring (24-hour Holter monitoring), as well as measurement of a series of plasma biochemical indices. The study will examine the potential prognostic role of CPET variables (such as peak VO2) in the future recurrences of paroxysmal atrial fibrillation.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Christodoulos E. Papadopoulos, PhD; Phone Number: +30 2310892343; Email: chrpapado@gmail.com
• Study Contact Backup: Name: Aristi C. Boulmpou, MSc; Phone Number: +30 2310892343; Email: aristi_bou1993@yahoo.gr

Study Locations

• Greece
  • Thessaloniki
    • Thessaloníki, Thessaloniki, Greece, 54642
      • Recruiting
      • Ippokratio General Hospital
      • Contact: Aristi C. Boulmpou, MSc; Phone Number: +30 2310892343; Email: aristi_bou1993@yahoo.gr
      • Principal Investigator: Christodoulos E. Papadoupoulos, PhD
      • Principal Investigator: Aristi C. Boulmpou, MSc
      • Sub-Investigator: Eva Pella, MD
      • Sub-Investigator: Vassilios P. Vassilikos, PhD
      • Sub-Investigator: Afroditi K. Boutou, PhD
      • Sub-Investigator: Pantelis Sarafidis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with paroxysmal atrial fibrillation, at least 2 weeks after the last atrial fibrillation episode, are eligible for the study.

Description

Inclusion Criteria:

1. Patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation)
2. Age > 18 years
3. Capability of providing written consent
4. Patients able to undergo cardiopulmonary exercise testing
5. Patients able to comply with the follow-up schedule of the study

Exclusion Criteria:

1. Patients with structural cardiomyopathy
2. Patients with congenital heart disease
3. Patients with permanent atrial fibrillation
4. Patients who have undergone atrial fibrillation ablation
5. Patients with implanted cardiac devices for primary or secondary prevention
6. Patients with recent (within the last month) acute coronary syndrome
7. Patients with heart failure with reduced ejection fraction (HFrEF) or end-stage renal disease
8. Patients with autoimmune diseases or active malignancies
9. Patients with uncontrolled thyroid disease
10. Patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues
11. Patients who present with contraindications for cardiopulmonary exercise testing
12. Patients unable to provide written consent
13. Patients with poor echocardiographic images
14. Patients unable to undergo spirometry
15. Patients unable to comply with the follow-up schedule of the study
16. Patients with uncontrolled hypertension
17. Patients who have undergone recent (within the last 2 months) surgery
18. Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation group; Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm	Diagnostic test: Observation group; Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new atrial fibrillation paroxysms	The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.	2 months
Number of new atrial fibrillation paroxysms	The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.	6 months
Number of new atrial fibrillation paroxysms	The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation - related hospitalizations	The total number of atrial fibrillation - related hospitalizations	2 months - 6 months - 12 months
Type of cardioversions	In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous)	2 months - 6 months - 12 months
Total burden of premature atrial contractions	Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Total burden of premature ventricular contractions	Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring	Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Microvolt T-wave Alternans (TWA)	Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings	Baseline and 12 months
Heart rate turbulence (HRT)	Heart rate turbulence (HRT) is the baroreflex-mediated short-term oscillation of cardiac cycle lengths after spontaneous ventricular premature complexes. Specialist software detects abnormal HRT in patients' 24-hour ambulatory electrocardiographic monitor recordings	Baseline and 12 months
Deceleration capacity (DC)	(Heart rate) deceleration capacity is a measurement of autonomic nerve regulation in heart failure. Specialist software quantifies deceleration capacity, which is measured in milliseconds (ms).	Baseline and 12 months
Peak oxygen uptake (peak VO2)	Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing	Baseline
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)	Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing	Baseline
Left atrial strain	Left atrial strain measured during echocardiographic study	Baseline and 12 months
Left ventricular global longitudinal strain (GLS)	Left ventricular global longitudinal strain (GLS) measured during echocardiographic study	Baseline and 12 months
Plasma biomarkers	Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI)	Baseline and 12 months
Time to first recurrence	Time from baseline to first recurrence of atrial fibrillation	12 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: General Hospital Of Thessaloniki Ippokratio
• Investigators: Principal Investigator: Aristi C. Boulmpou, MSc, Aristotle University of Thessaloniki, Greece; Principal Investigator: Christodoulos E. Papadopoulos, PhD, Aristotle University of Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2020
• Primary Completion (ANTICIPATED): December 10, 2024
• Study Completion (ANTICIPATED): December 10, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: exercise capacity; atrial fibrillation; echocardiography; cardiopulmonary exercise testing; peak oxygen uptake; holter monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 29551/30.6.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No